FDA Requests Marketing Suspension of Trasylol

ROCKVILLE, Md., Nov. 5, 2007-The U.S. Food and Drug
Administration (FDA) today announced that, at the agency's request,
Bayer Pharmaceuticals Corp. has agreed to a marketing suspension of
Trasylol, a drug used to control bleeding during heart surgery,
pending detailed review of preliminary results from a Canadian
study that suggested an increased risk for death.

FDA requested the suspension in the interest of patient safety
based on the serious nature of the outcomes suggested in the
preliminary data. FDA has not yet received full study data but
expects to act quickly with Bayer, the study's researchers at the
Ottawa Health Research Institute, and other regulatory agencies to
undertake a thorough analysis of data to better understand the
risks and benefits of Trasylol.

There are not many treatment options for patients at risk for
excessive bleeding during cardiac surgery. Thus, FDA is working
with Bayer to phase Trasylol out of the marketplace in a way that
does not cause shortages of other drugs used for this purpose.

Until FDA can review the data from the terminated study it is
not possible to determine and identify a population of patients
undergoing cardiac surgery for which the benefits of Trasylol
outweigh the risks. Understanding that individual doctors may
identify specific cases where benefit outweighs risk, FDA is
committed to exploring ways for those doctors to have continued,
limited access to Trasylol.

Two weeks ago, FDA was notified that researchers with the Ottawa
Health Institute stopped a study on Trasylol because the drug
appeared to increase the risk for death compared to two other
antifibrinolytic drugs used in the study. Antifibrinolytic drugs
help slow the breakdown of blood clots and subsequent excessive
bleeding. The preliminary data from this terminated study also
suggested that fewer patients receiving the drug experienced
serious bleeding events.

On Oct. 26, FDA issued an Early
Communication about an Ongoing Safety Review of Trasylol in
response to the Canadian study's termination. In 2006, FDA revised
the labeling for Trasylol to strengthen its safety warning and
limit its approved usage to patients at an increased risk for blood
loss and blood transfusion during coronary bypass graft
surgery.